Guidances Under Development for 2021
Center for Veterinary Medicine (CVM) Guidance Documents Under Development
(Expected to publish as drafts or finals by the end of December 2021.)
Introduction
The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the CVM is considering. We currently intend to develop guidance on each topic; however, the Center is neither bound by this list of topics, nor required to issue every guidance document on this list. We are not precluded from developing guidance documents on topics not on this list. This list includes Compliance Policy Guides.
Guidance for Industry (GFI)
| Title of Guidance | Contact |
|---|---|
| GFI #187 – Regulation of Intentionally Altered Genomic DNA in Animals (Revision) | Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7500 Standish Place, Rockville, MD 20855, 301-796-8558, [email protected] |
| Draft GFI #251 – Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease | Laura R. Epstein, Center for Veterinary Medicine (HFV-1), 7500 Standish Place, Rockville, MD 20855, 301-796-8558, [email protected] |
| GFI #61 – Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Revision) | Margaret Oeller, Center for Veterinary Medicine (HFV-50), 7500 Standish Place, Rockville, MD 20855, 240-402-0566, [email protected] |
| Draft GFI #253 – Good Manufacturing Practices for Animal Cells, Tissues, and Cell- or Tissue-Based Products | Lynne Boxer, Center for Veterinary Medicine (HFV-114), 7500 Standish Place, Rockville, MD 20855, 240-402-0611, [email protected] |
| Draft GFI #254 – Donor Eligibility for Animal Cells, Tissues, and Cell- or Tissue-Based Products | Lynne Boxer, Center for Veterinary Medicine (HFV-114), 7500 Standish Place, Rockville, MD 20855, 240-402-0611, [email protected] |
| Draft GFI #228 – Designing Effectiveness Studies for Drugs Intended to Enhance Animal Production (Growth, Feed Efficiency, Carcass Leanness, Reproduction, Milk Production) | Amey Adams, Center for Veterinary Medicine (HFV-126), 7500 Standish Place, Rockville, MD 20855, 240-402-0816, [email protected] |
| Draft GFI #152 – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern (Revision) | Jeffrey Gilbert, Center for Veterinary Medicine, (HFV-157), 7500 Standish Place, Rockville, MD 20855, 240-402-0706, [email protected] |
| GFI #171 – Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media (Revision) | Lauren Feeney, Center for Veterinary Medicine (HFV-170), 7500 Standish Place, Rockville, MD 20855, 240-402-0848, [email protected] |
| GFI #261 – Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs | Christopher Loss, Center for Veterinary Medicine (HFV-110), 7500 Standish Place, Rockville, MD 20855, 240-402-0619, [email protected] |
| GFI #263 – Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter | John Mussman, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-0589, [email protected] |
| Draft GFI #___ – New Chemical Entity Exclusivity for Certain Combination New Animal Drug Products | Patrice Brooks-Gelling, Center for Veterinary Medicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-7384, [email protected] |
| Draft GFI #___ – Feed-Use Combinations: Recommendations for Satisfying Approval Requirements Under the Animal Drug Availability Act (ADAA) | Hilary Hoffman, Center for Veterinary Midicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, [email protected] |
| Draft GFI #___ – Dosage Form Combinations: Recommendations for Satisfying Approval Requirements | Hilary Hoffman, Center for Veterinary Midicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, [email protected] |
| Draft GFI #106 – The Use of Published Literature in Support of New Animal Drug Applications (Revision) | Amey Adams, Center for Veterinary Medicine (HFV- 120), 7500 Standish Place, Rockville, MD 20855, 240-402-0816, [email protected] |
| Draft GFI #260 - Type VII Veterinary Master File for Pre-Investigational Development and Research Involving Novel or Rapidly Evolving Technologies | Hilary Hoffman, Center for Veterinary Midicine (HFV-108), 7500 Standish Place, Rockville, MD 20855, 240-402-8406, [email protected] |
| GFI #265 – Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs | Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578, [email protected] |
| GFI #266 – Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs | Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578, [email protected] |
| GFI #267 – Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs | Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578, [email protected] |
| GFI #268 – Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs | Susan Storey, Center for Veterinary Medicine (HFV-131), 7500 Standish Place, Rockville, MD 20855, 240-402-0578, [email protected] |
| Draft GFI #273 – Recommendations for Sponsors of Medically-Important Antimicrobial Drugs Approved for Use in or on Medicated Feed of Food-Producing Animals for Establishing Appropriately Defined Durations of Use Where None Currently Exist | John Mussman, Center for Veterinary Medicine (HFV-133), 7500 Standish Place, Rockville, MD 20855, 240-402-0589, [email protected] |
| GFI #245 – Hazard Analysis and Risk-Based Preventive Controls for Food for Animals | Jeanette Murphy, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Rockville, MD 20855, 240-402-6246, [email protected] |
| GFI #246 – Hazard Analysis and Risk-Based Preventive Control: Supply-Chain Program | Jeanette Murphy, Center for Veterinary Medicine (HFV-200), 7519 Standish Place, Rockville, MD 20855, 240-402-6246, [email protected] |
| Draft GFI #120 – Veterinary Feed Directive Regulation Questions and Answers (Revision) | Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-5944, [email protected] |
| GFI #256 – Compounding Animal Drugs from Bulk Drug Substances | Eric Nelson, Center for Veterinary Medicine (HFV-230), 7519 Standish Place, Rockville, MD 20855, 240-402-5642, [email protected] |
| Draft GFI #258 – Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds | Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, [email protected] |
| Draft GFI #272 – Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover | Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, [email protected] |
| Draft GFI #___ – Devices for Use in Animals (Revision) | Diana Link, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Rockville, MD 20855, 240-402-6215, [email protected] |
| Draft GFI #___ – Food Ingredients for the Control of Halitosis (Bad Breath) in Pets | Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, [email protected] |
Compliance Policy Guide (CPG)
(Sub Chapter 600-659 – Veterinary Drugs; Sub Chapter 660-699 – Animal Feed)
| Title of CPG | Contact |
|---|---|
| Draft CPG Sec. 654.200 – Teat Dips and Udder Washes for Dairy Cows and Goats (Revision) | Diana Link, Center for Veterinary Medicine (HFV-214), 7519 Standish Place, Rockville, MD 20855, 240-402-6215, [email protected] |
| Draft CPG Sec. 665.100 – Common or Usual Names of Animal Food Ingredients and the Use of Ingredients Listed in the Official Publication of the Association of American Feed Control Officials in Animal Food (Revision) | Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, [email protected] |
| Draft CPG Sec. 689.100 – Direct-Fed Microbial Products (Revision) | Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, [email protected] |
| Draft CPG Sec. 687.500 – Silage Ingredients (Revision) | Sara Sklenka, Center for Veterinary Medicine (HFV-226), 7519 Standish Place, Rockville, MD 20855, 240-402-6680, [email protected] |